Internal Support Regulatory Writing

Criterion Edge can support your internal document writing requirements

Our team of regulatory writers and QC reviewers understand the workflow pressures within organizations, which are often the result of multiple or urgent requests for updates, amendments, new documentation practices or a lack of resources.

Let us help. Put our writers and support team to work on your internal writing needs. Listed here are just a few examples of the deliverables we can provide. Whatever your requirements and budget may be, Criterion Edge provides the capacity and flexibility to meet your needs.

Contact us for a free consult on your current needs.

Key Internal Support Deliverables include:

  • Protocols and Clinical Investigation Plans SOPs
  • Informed Consent Forms
  • Clinical Narratives
  • Evidence Gap Assessments
  • Briefing Documents
  • Working Group/KOL Advisory Board Summaries
  • Response Documents

[WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions

In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.

Attendees are eligible for a free consultation and scan of their CER. Spots are limited – click to register for this free webinar.